US Regulatory Affairs Lead

US Regulatory Affairs Lead (Contract)

I'm partnering with an innovative biotechnology company seeking an experienced US Regulatory Affairs Lead to support regulatory strategy and execution across new products and indication expansions. This is an excellent opportunity for a well-rounded Regulatory Affairs professional with strong US FDA strategy and submission experience who can confidently partner with cross-functional teams and clearly communicate regulatory approaches and recommendations.

Requirements

• Bachelor's degree in a relevant scientific discipline; advanced degree is a plus

• 7+ years of Regulatory Affairs experience within a biotechnology, pharmaceutical, or related environment

• Strong knowledge of US FDA regulatory requirements and submission processes

• Hands-on experience with IND, NDA, and/or BLA submissions

• Strong experience developing and executing US regulatory strategy, in addition to tactical regulatory activities

• Broad Regulatory Affairs experience, particularly across Clinical/Nonclinical or general regulatory activities

• Strong communication skills with the ability to clearly explain regulatory strategy, decisions, and previous project experience

• Experience working effectively with cross-functional and global regulatory teams

Responsibilities

• Support US regulatory strategy and project deliverables for new products and indication expansions

• Serve as the US Regulatory Lead for assigned products or indication expansion programs

• Represent the US Regulatory function on cross-functional teams, including clinical study teams, oncology workgroups, and global regulatory teams

• Prepare for and support FDA meetings, including regulatory research, regulatory intelligence, briefing materials, and presentations

• Lead and support preparation and submission of INDs, NDAs, and BLAs

• Partner with assigned resources on regulatory submission maintenance activities

• Conduct regulatory research and provide guidance on US FDA requirements and expectations

• Develop and coordinate end-to-end regulatory submission process descriptions

• Provide regulatory input and strategic guidance to cross-functional development teams

• Support US regulatory assessments of external innovation and business development opportunities

• Collaborate with Global Regulatory Leads and other US Regulatory colleagues on assigned programs

Preferred

• Experience in oncology or other complex therapeutic areas

• Experience leading regulatory strategy across multiple development programs

• Broad regulatory experience beyond a single specialty such as CMC, publishing, regulatory operations, policy, or regulatory intelligence

• Experience preparing for FDA meetings and communicating regulatory strategy to senior stakeholders

Interviews are starting soon, so if you're interested and would like to be considered, give me a call at (919) 892-9841 as soon as you're available.